Medidata Solutions ((MDSO)), AstraZeneca ((AZN)), AstraZeneca plc ((GB:AZN)), AstraZeneca ((DE:ZEGA)), AstraZeneca plc US ((AZNCF)) announced an update on their ongoing clinical study.
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
AstraZeneca, in collaboration with Medidata Solutions and other industry partners, is conducting a Phase III clinical study titled ‘A Phase III Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis in Pediatric Patients 1 to 11 Years of Age.’ The study aims to evaluate the safety and efficacy of Nexium in maintaining healing of erosive esophagitis in children aged 1 to 11 years, a condition not yet approved for treatment in the United States.
The intervention involves two doses of Nexium, a drug known as Esomeprazole, administered as gastro-resistant granules for oral suspension. The study tests a high dose (20mg) and a low dose (10mg) to determine their effectiveness in maintaining healing over a 16-week period.
This interventional study employs a randomized, parallel assignment model with quadruple masking, ensuring that participants, care providers, investigators, and outcomes assessors are blinded to the treatment allocations. The primary purpose of the study is treatment-focused.
The study began on July 1, 2022, and is currently recruiting participants. The last update was submitted on July 28, 2025. These dates are crucial as they indicate the study’s progression and ongoing nature.
The outcome of this study could significantly impact AstraZeneca’s market position, particularly if Nexium receives approval for pediatric use in the U.S. This could enhance investor confidence and potentially influence stock performance positively, especially in comparison to competitors lacking similar pediatric approvals.
The study is ongoing, with further details available on the ClinicalTrials portal.